Bullish things for MNTA that could happen at almost any time:
• FDA tentative approval of MNTA’s Copaxone ANDA, which would allow MNTA to launch generic Copaxone at the expiration of Teva’s Orange Book patents in May 2014.
• A partnership deal for M402.
• Announced progress on one or more of the compounds in the FoB program with BAX (#msg-81498217, #msg-70258421).
• A buyout offer.
None of these individual items (except perhaps the first one) is especially likely to happen soon; however, the probability that at least one of the above events happens in a given time period is clearly much greater than the probability of any specific event.
[Removed obsolete item re 2Q13 CC, which was held on 8/1/13.]
Copaxone program
• Timing uncertain: FDA action on MNTA’s Copaxone ANDA. If FDA approval comes before 5/24/14, it would require that MNTA hold off on launching until Teva’s patents expire on 5/24/14.
• Timing uncertain: FDA action on Mylan’s Copaxone ANDA. If FDA approval comes before 5/24/14, it would require that Mylan hold off on launching until Teva’s patents expire on 5/24/14. (MYL’s Copaxone ANDA was accepted for FDA review 14 months after MNTA’s ANDA.)
FoB program
• Early 2014: Start of clinical trial for M923, the first compound in the BAX-MNTA FoB collaboration (which I think is Orencia). This will trigger two milestone payments from BAX (#msg-81498217). Note: MNTA has already established proof of concept on this compound.
• Early 2014: BAX decision whether to license M511, the third compound in the BAX-MNTA collaboration (which I think is Erbitux). If BAX licenses M511, MNTA will receive an up-front license fee and be eligible for additional milestone payments on this compound (#msg-81498217).
• Timing uncertain: Pre-IND progress on M834, the second compound in the BAX-MNTA collaboration (which I think is Humira). BAX has already licensed this product for further development.
• Timing uncertain: Selection of the fourth, fifth, and sixth FoB compounds to be developed in the BAX-MNTA collaboration (if any).
Other programs
• 1H14: M402 data (safety, tolerability, efficacy to determine dose(s) for further study) from first portion of phase-1/2 trial in pancreatic cancer. The revised trial design (adding Abraxane as a comparator) is listed at http://www.clinicaltrials.gov/ct2/show/NCT01621243 . Data from the second (randomized) portion of the trial is expected in Jan 2015.
• Timing uncertain: Progress on IVIG program based on the sialic switch technology.
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